Clinical Trials Start-Up Specialist
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
University of Colorado | CU Anschutz Medical CampusSchool of Medicine, The Cancer CenterClinical Trials Start-Up SpecialistResearch Services Sr. ProfessionalPosition #782529 – Requisition #20743* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The Cancer Center has an opening for a [full-time/part-time] University Staff (unclassified) Clinical Trials Start-Up Specialist position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report. The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.The CU Cancer Center’s vision is to “prevent and conquer cancer. Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”Nature of WorkThe CU Cancer Center is looking to hire a full time Start-up Specialist to participate in the implementation and conduct of clinical research trials within the Cancer Center Clinical Trials Office (CCTO) by developing relationships with sponsors and customers.Professional Field: Clinical Research/Clinical Trials AdministrationSupervision Received: CCTO Senior Project ManagerSupervision Exercised: N/AExamples of Work Performed
Qualifications
Minimum Requirements
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Mar 31, 2021
Unposting Date: Ongoing
University of Colorado | CU Anschutz Medical CampusSchool of Medicine, The Cancer CenterClinical Trials Start-Up SpecialistResearch Services Sr. ProfessionalPosition #782529 – Requisition #20743* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.The Cancer Center has an opening for a [full-time/part-time] University Staff (unclassified) Clinical Trials Start-Up Specialist position.The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. The University of Colorado (CU) Cancer Center headquartered at the Anschutz Medical Campus and part of the CU School of Medicine. It is Colorado’s only National Cancer Institute-designated comprehensive cancer center, a distinction recognizing its outstanding contributions to research, clinical trials, prevention and cancer control. CU Cancer Center’s clinical care sites are UCHealth, University of Colorado Hospital and Children’s Hospital Colorado are ranked nationally by U.S. News and World Report. The CU Cancer Center is a member of the prestigious National Comprehensive Cancer Network®, an alliance of the nation’s leading cancer centers working to establish and deliver the gold standard in cancer clinical guidelines. CU Cancer Center also is a member of the Oncology Research Information Exchange Network (ORIEN), a unique research partnership among North America’s top cancer centers leveraging multiple data sources and matching patients to targeted treatments. CU Cancer Center is a consortium of approximately 300 researchers and physicians at three state universities and three healthcare delivery institutions.The CU Cancer Center’s vision is to “prevent and conquer cancer. Together.” We do this through our mission statement of “uniting our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care and education.”Nature of WorkThe CU Cancer Center is looking to hire a full time Start-up Specialist to participate in the implementation and conduct of clinical research trials within the Cancer Center Clinical Trials Office (CCTO) by developing relationships with sponsors and customers.Professional Field: Clinical Research/Clinical Trials AdministrationSupervision Received: CCTO Senior Project ManagerSupervision Exercised: N/AExamples of Work Performed
- Serves as main study contact person for the entire CCTO department for new/ongoing clinical research studies and meets with representatives from sponsoring pharmaceutical firms or in-house staff for initial orientation to studies and for review of regulatory records.
- Collaborate with sponsor at a high level to cultivate and expand upon existing relationships.
- Coordinate and attends site qualification visits for multiple disease sites.
- Completes feasibility questionnaires for multiple disease sites.
- Tracks new and declined studies across 10+ disease sites.
- Completes prioritization documents for PRMC across 10+ disease sites.
- Submits CDAs for review/negotiation across 10+ disease sites.
- Participates in Data Safety Monitoring Committee (DSMC) activities.
- Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents through ongoing training.
- Negotiates for increasing use of internal resources in order to utilize institutional assets that could result in higher efficiency and quality.
- Serves as direct liaison with budget and finance, assisting in escalations of contract and budget negotiation with sponsors and CROs.
- Serves as a direct liaison with sponsor/CRO medical monitors.
- Facilitates Pipeline Discussions with sponsor/CRO’s across 10+ disease sites.
- Takes responsibility for meeting internal and external timelines.
- Attends clinical team meetings and SIV visits as necessary.
- Assists in escalation of sponsor and CRO related concerns and communication issues.
- Manages Sponsor Information Portals
- Serves as back-up to budget assistants for CDA routing across 10+ disease sites.
Qualifications
Minimum Requirements
- BS or BA in Biology, Chemistry, Physiology, Behavioral Sciences, Nursing , Business Administration, Accounting, Human Biology, Public Policy, Communications, Psychology, or Public Health or related field
- A minimum of 2 years clinical research experience
- Two (2) years’ oncology experience (clinical or research)
- Four (4) years’ clinical, research or clinical research experience
- Experience working with Cancer Therapy Evaluation Program and PI initiated studies
- Experience working in an academic medical setting
- Experience in teaching, precepting and mentoring employees to clinical research.
- Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
- Understands the phases and concepts of clinical trials and the overall philosophies of conducting cooperative group research as they differ with NCI sponsored, private industry and investigator initiated clinical trials.
- Demonstrates the quick ability to learn, interpret and master complex protocol information.
- Knowledge of study budgets and contracts.
- Understanding of computer systems (specifically MS Office Suite) and ability to work efficiently within various applications.
- Possesses advanced knowledge of Good Clinical Practices, FDA Rules and Regulations in relation to clinical trials, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical trials, and NCI common toxicity definitions.
- Knowledge of basic human anatomy, physiology, and medical/pharmaceutical terminology
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Mar 31, 2021
Unposting Date: Ongoing
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